A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight and Obesity

In brief

The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with Mazdutide compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

Key facts

Study ID

NCT06124807

Run by

Eli Lilly and Company

People needed

179

Starts

2023-11-17

Expected to finish

2025-07-09

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• W8M-MC-OXA1:
• Are males and females who agree to abide by the reproductive and contraceptive requirements
• W8M-MC-CWMM:
• Have a BMI ≥27 kilograms per square meter (kg/m²)

You may not qualify if…

• W8M-MC-OXA1:
• Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.
• Have any of the following cardiovascular conditions within 6 months prior to screening:
• acute myocardial infarction
• cerebrovascular accident (stroke)
• unstable angina, or
• hospitalization due to congestive heart failure (CHF).
• Have a history of New York Heart Association (NYHA) Functional Classification I-IV CHF.
• Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening.
• Have a history of acute or chronic pancreatitis.
• Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.
• CWMM:
• Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
• Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
• Have poorly controlled hypertension.
• Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
• Have a history of symptomatic gallbladder disease within the past 2 years.
• Have a lifetime history of suicide attempts.

Where it is running

• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler, Arizona, United States
• Headlands Research - Scottsdale — Scottsdale, Arizona, United States
• The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson, Arizona, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Northeast Research Institute (NERI) — Fleming Island, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Charter Research - Winter Park — Orlando, Florida, United States
• Charter Research - Lady Lake — The Villages, Florida, United States
• Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
• Great Lakes Clinical Trials - Andersonville — Chicago, Illinois, United States
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Knownwell — Needham, Massachusetts, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Dent Neurologic Institute — Amherst, New York, United States
• North Suffolk Neurology — Port Jefferson Station, New York, United States
• Lucas Research, Inc. — New Bern, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Quality Medical Research — Nashville, Tennessee, United States
• IMA Clinical Research Austin — Austin, Texas, United States
• Velocity Clinical Research, Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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